Medical writing: vigilance for ethics
By Robert Hand (robert.hand@rxcomm) As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New…
American Medical Writers Association (AMWA) Annual Conference 2008
By Robert Hand (robert.hand@rxcomms.com) Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky…
Development Safety Update Reports (DSURs): simplifying periodic safety reporting
The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR.
Training programmes: Where do future health economists come from?
By Robert Hand (robert.hand@rxcomms.com) For those interested in entering or advancing in the field of health economics and outcomes research, and for those looking for newly-minted researchers to employ, it…
You need to know the global issues in health economics
By Robert Hand (robert.hand@rxcomms.com) As a health economist and outcomes researcher, you may work primarily within a single country. Naturally, you know the economic, regulatory, and management issues of that…
AMWA Annual Conference 2007
By Robert Hand (robert.hand@rxcomms.com) Under the title Legacy of Leadership, the American Medical Writers Association (AMWA) held its 67th Annual Conference on October 11–13 in Atlanta, Georgia. About 1000 medical…
Understanding study design in comparing drug studies
By Robert Hand (robert.hand@rxcomms.com) For a variety of reasons, pharmaceutical manufacturers often do not conduct head-to-head studies of their drugs versus the competition. On the other hand, head-to-head studies are…
Getting drugs accepted: who succeeds and why
By Robert Hand Health economics data play an increasingly important role in getting pharmaceuticals accepted for the drug formularies established by health insurance plans and regulatory authorities. A drug manufacturer…
Getting the word out without giving away trade secrets
By Robert Hand In the United States, there has been growing acceptance of the Academy of Managed Care Pharmacy (AMCP) Drug Dossier format for submitting consistent, evidence-based information about drugs.…